The aim of this study is to determine the feasibility to perform laparoscopic HIPEC in colorectal cancer patients at high risk of PC in a short stay setting.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is hospital stay.
Secondary outcome
Secondary endpoints are treatment related morbidity defined as surgical
complications and toxicity related to the intraperitoneal chemotherapy.
Background summary
The peritoneum is the second most common site of recurrence in patients with
colorectal cancer. Cytoreductive surgery and hyperthermic intraperitoneal
chemotherapy (CR/HIPEC) in patients with peritoneal carcinomatosis (PC) has
been shown to improve survival, but the effectiveness depends highly on the
extent of disease. Furthermore, open CR/HIPEC has a substantial complication
rate. It seems therefore attractive to treat patients at high risk of PC in an
adjuvant setting. Incidences of PC range from 19% in pT4 stage to 75% in
patients with isolated ovarian metastases. Because PC is often difficult to
detect by imaging modalities, these incidences may be even higher. A
laparoscopic HIPEC procedure is potentially an effective oncological procedure
with all the advantages of a minimally invasive approach.
Study objective
The aim of this study is to determine the feasibility to perform laparoscopic
HIPEC in colorectal cancer patients at high risk of PC in a short stay setting.
Study design
Included patients will undergo laparoscopic HIPEC 4 to 8 weeks after resection
of the primary tumour. Subsequently patients will receive adjuvant systemic
chemotherapy within 3 to 6 weeks from HIPEC.
Intervention
The laparoscopic HIPEC procedure: open introduction of a 10 mm trocar at the
umbilicus, CO2 pneumoperitoneum, three additional trocars of 10 mm, complete
dissection of adhesions, peritonectomy or other cytoreductive surgery if
indicated, two inflow catheters (right upper quadrant and left paracolonic
gutter), one outflow catheter (Douglas pouch), perfusion with a minimum of 2l
isotonic dialysis fluid at a flow rate of 1-2l/min and an inflow temperature of
42-43*C, Mitomycin C (17.5 mg/m2 followed by 8.8 mg/m2 every 30 minutes), 90
minutes perfusion time.
Study burden and risks
Patients will have to undergo a laparoscopic HIPEC procedure in short stay
setting. Potential risks are woundinfection, gastroparesis or temporary
bonemarrow depression, intra-abdominal abcess, and operation associated risks.
Benfit is the possible prevention of peritoneal metastasis, however this is not
yet confirmed in studies.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients diagnosed with adenocarcinoma of the colon and proximal rectum and at least one of the following risk factors for PC will be considered for inclusion:
* pT4
* (Resected) local peritoneal nodules in the close proximity of the primary tumour
* Primary tumour presenting with obstruction and/or perforation
* Positivie cytology in peritoneal lavage
* Ovarian metastasis or omental metastasis;Eligibility criteria are:
* age between 18 and 75 years,
* ECOG performance status 0 to 2,
* written informed consent obtained prior to any study specific screening procedures,
* white blood cell count at least 3000/mm3, platelet count at least 100.000/mm3,
* no bleeding diathesis or coagulopathy,
* creatinine normal or creatinine clearance at least 50 ml/min
Exclusion criteria
* liver and/or lung metastases,
* pregnant or lactating women,
* unstable or uncompensated respiratory or cardiac disease,
* serious active infections,
* other concurrent chemotherapy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-023675-26-NL |
| CCMO | NL34574.018.10 |